Hidden TB risks: study links diet, diabetes, and parasites to latent infection
NCT ID NCT04526613
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study explored why some people with latent (inactive) tuberculosis (TB) are more likely to develop active TB. Researchers looked at 626 people in South India to see how malnutrition, diabetes, and worm infections might change the body's response to TB. Participants gave blood, urine, and stool samples and had physical exams. The goal was to better understand these risk factors, not to test a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
626 people
The number who actually took part.
- Started
-
Apr 2021
- Finished
-
Mar 2026
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants will be recruited from villages in the Kancheepuram District in south India. The census in villages in the Kancheepuram District is updated annually by local health workers employed by the Department of Public Health and the field teams of the NIRT in Chennai, India. The villages will be chosen in consultation with the Department of Public Health in Tamil Nadu.
- Ages
-
14 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* PARTICIPANT INCLUSION CRITERIA (Screening Phase) Individuals who meet the following criteria are eligible to participate in the screening phase: * Aged 14 to 65 years. * Willingness to provide blood, urine, and stool samples for examination. * Willingness to have samples and data stored. * Able to provide informed consent. PARTICIPANT EXCLUSION CRITERIA (Screening Phase) * Pulmonary symptoms suggestive of TB (cough \>2 weeks in duration and/or intermittent fever \>1 week in duration and/or hemoptysis). * Two IGRA tests with indeterminate results (mitogen values \<10 IU). PARTICIPANT INCLUSION CRITERIA (Study Phase) Individuals are eligible for the study phase if they meet the requirements for one of the study groups, as follows: 1. LTBI+ and severe to moderate malnutrition (BMI \<17 kg/m2); 2. LTBI+ and uncontrolled DM (HbA1c \>8%); 3. LTBI+ and helminth infection (positive stool qPCR and/or serology); 4. LTBI+ with more than one of the conditions defined in groups 1 3; 5. healthy LTBI+ controls who are negative for all of the above conditions; and 6. healthy LTBI-negative controls with none of the above conditions. PARTICIPANT EXCLUSION CRITERIA (Study Phase) * Pulmonary symptoms suggestive of TB (cough \>2 weeks in duration and/or intermittent fever \>1 week in duration and/or hemoptysis). * Pregnant or lactating women. * Previous treatment for LTBI. * Anemia with hemoglobin \<8 g/dl (evaluated at the screening phase visit). * For LTBI+ participants, clinically indicated chest X-ray positive for pulmonary TB. * For malnourished participants, clinically indicated abdominal ultrasound positive for abdominal TB. * Known documented cases of cancer, acquired immune deficiency syndrome, or other immunosuppressive illness. * History of any other illness or condition which, in the investigator s judgment, may substantially increase the risk associated with the participant s participation in the protocol, or compromise the scientific objectives.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetes mellitus are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
National Institute for Research In Tuberculosis, International Centers for Exel
Chennai, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Four-Part check may reveal hidden malnutrition in sickest kids
- Sickle cell clues to diabetes risk hidden in DNA
- Can protein shakes help older veterans bounce back after surgery?
- Why do some malnourished infants recover and others Don't? hospitals track every gram
- Can coconut oil and moringa rinses fight gum disease in diabetic kids?
- Eye scans as a window to the body: study probes retinal imaging across diseases